Management of Gastrointestinal Bleeding Under Direct Oral Anticoagulants

Management of Gastrointestinal Bleeding Under Direct Oral Anticoagulants: Analysis of Reversal Practices Using Prothrombin Complex at the Strasbourg University Hospitals

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07333144

Acronym

HEMOD-AOD

Enrollment

250

Registered

2026-01-12

Start date

2025-02-28

Completion date

2026-06-28

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Bleeding

Keywords

Gastrointestinal bleeding, Hepatogastroenterology, Direct oral anticoagulants

Brief summary

Gastrointestinal bleeding (GIB) is a common emergency in hepatology and gastroenterology, with an overall mortality rate ranging from 5% to 10% depending on the study. GIB is classified into two categories: upper GIB (80% of cases) and lower GIB (20% of cases). There are many risk factors for GIB, including anticoagulants. In cases of GD under anticoagulants, there are specific management recommendations. In particular, in cases of severe bleeding under direct oral anticoagulants (DOACs), it is recommended to stop treatment and correct coagulation parameters according to the severity of the bleeding and the associated thrombotic risk. Various treatments can be used for this purpose, including specific antidotes, fresh frozen plasma, and prothrombin complex concentrate (PCC). However, the role of PCC in this indication is uncertain, as is the efficacy and safety data for this drug, due to significant methodological limitations in the few studies conducted on the subject.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patient (≥ 18 years) * Male or female * Patient admitted to the emergency department for gastrointestinal bleeding (hematemesis, melena, rectal bleeding, or hematochezia) * Taking a direct oral anticoagulant (dabigatran, apixaban, or rivaroxaban)

Exclusion criteria

* Subject who has expressed their objection to the reuse of their data for scientific research purposes. * Subject under guardianship, curatorship, or legal protection.

Design outcomes

Primary

Measure	Time frame	Description
Proportion of patients on direct oral anticoagulants admitted to the emergency department of Strasbourg University Hospital	48 hours following patient admission	Proportion of patients on direct oral anticoagulants admitted to the emergency department of Strasbourg University Hospital for gastrointestinal bleeding who received prothrombin complex concentrate within the first 48 hours of admission.

Countries

France

Contacts

Primary ContactValérie WILME, MD

valerie.wilme@chru-strasbourg.fr33 3 88 11 67 68

Outcome results